MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD HYPODERMIC NEEDLE PRECISIONGLIDE¿ WITHOUT SAFETY; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305156
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 8172859.Medical device expiration date: 2023-08-31.Device manufacture date: 2018-06-21.Medical device lot #: 8090593.Medical device expiration date: 2023-06-30.Device manufacture date: 2018-03-31.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that bd hypodermic needle precisionglide¿ without safety was cloudy.This was discovered before use.The following information was provided by the initial reporter: material no.305156, batch no.Unknown (customer provided 8172859 & 8090593) it was reported when patient drew medication into the syringe it turned cloudy.Complaint description: pt's husband prepared gattex vial as directed for injection.Everything looked normal.As he was trying to pull up the medicine into the syringe as directed, the solution turned cloudy.This had never happened before.He discarded the vial and used a new one and everything was fine with that vial.No adverse effects noted.No other information known.
Event or Problem Description
It was reported that bd hypodermic needle precisionglide¿ without safety was cloudy.This was discovered before use.The following information was provided by the initial reporter: material no.305156 batch no.Unknown (customer provided 8172859 & 8090593) it was reported when patient drew medication into the syringe it turned cloudy.Complaint description: pt's husband prepared gattex vial as directed for injection.Everything looked normal.As he was trying to pull up the medicine into the syringe as directed, the solution turned cloudy.This had never happened before.He discarded the vial and used a new one and everything was fine with that vial.No adverse effects noted.No other information known.
Additional Manufacturer Narrative
Investigation: no samples or photos were provided by the customer for investigation.A device history record (dhr) review was performed on the batch associated with this investigation.The dhr reviews did not reveal any defects or issues reported and no quality notifications were issued.Based on the investigation conclusion and without a sample to analyze, the condition reported by the customer could not be confirmed nor could this symptom be correlated with a potential cause linked to the bd process.

• Brand Name: BD HYPODERMIC NEEDLE PRECISIONGLIDE¿ WITHOUT SAFETY
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 8895768
• Report Number: 1911916-2019-00804
• Device Sequence Number: 19515688
• Product Code: FMI
• UDI-Device Identifier: 30382903051565
• UDI-Public: 30382903051565
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K021475
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Catalogue Number: 305156
• Device Lot Number: SEE H.10
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/29/2019
• Supplement Date Received by Manufacturer: 07/29/2019
• Initial Report FDA Received Date: 08/14/2019
• Supplement Report FDA Received Date: 08/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other